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Набор скоро начнётся NCT07460726

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

— Наблюдательное Prostate Cancer (Adenocarcinoma) Erectile Abnormalities Sexual Dysfunction Male

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SBRT combined with ADT.
Кому может быть актуально
Состояния в реестре: Prostate Cancer (Adenocarcinoma), Erectile Abnormalities, Sexual Dysfunction Male. Базовые параметры: 18 лет — 80 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer

Обзор

This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.

Подробное описание

This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.

Вмешательства

  • Комбинированный продукт SBRT combined with ADT
    SBRT combined with Zoladex

Первичные конечные точки

  • Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score. [Срок оценки: Baseline, 3, 9, 15, and 24 months post-SBRT]
Вторичные конечные точки (5)
  • Proportion of patients with clinically significant (moderate to severe) erectile dysfunction [Срок оценки: Baseline, 3, 9, 15, and 24 months]
  • Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score [Срок оценки: Baseline, 3, 9, 15, and 24 months]
  • Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26) [Срок оценки: Baseline, 3, 9, 15, and 24 months]
  • Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8) [Срок оценки: Baseline, 3, 9, 15, and 24 months]
  • Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14 [Срок оценки: Baseline, 3, 9, 15, and 24 months (for patients >70 years)]

Критерии участия

Критерии включения

  • Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network \[NCCN\] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
  • Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
  • Baseline sexual function assessment available (International Index of Erectile Function \[IIEF-5, also known as SHIM\] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Written informed consent to participate.

Критерии исключения

  • Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
  • Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
  • Hypogonadism at presentation (baseline testosterone below normal range)
  • Contraindications to SBRT or ADT
  • Metastatic disease, second malignancy, or previous malignancies.
  • Benign or malignant penile diseases.
  • Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
  • Psychiatric conditions affecting questionnaire completion or QoL assessment
  • Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Manitoba Prostate Centre — Winnipeg

Публикации

  • Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361. PMID 17099194
  • Balachandran VP, Gonen M, Smith JJ, DeMatteo RP. Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7. PMID 25846097
  • Kennady EH, Bryk DJ, Ali MM, Ratcliffe SJ, Mallawaarachchi IV, Ostad BJ, Beano HM, Ballantyne CC, Krzastek SC, Clements MB, Gray ML, Rapp DE, Ortiz NM, Smith RP. Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial. Sex Med. 2023 Nov 11;11(5):qfad053. doi: 10.1093/sexmed/qfad053. eCollection 2023 Oct. PMID 37965376
  • Skolarus TA, Dunn RL, Sanda MG, Chang P, Greenfield TK, Litwin MS, Wei JT; PROSTQA Consortium. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. 2015 Jan;85(1):101-5. doi: 10.1016/j.urology.2014.08.044. PMID 25530370
  • Laviana AA, Hernandez A, Huang LC, Zhao Z, Koyama T, Conwill R, Hoffman K, Feurer ID, Goodman M, Hamilton AS, Wu XC, Paddock LE, Stroup A, Cooperberg MR, Hashibe M, O'Neil BB, Kaplan SH, Greenfield S, Penson DF, Barocas DA. Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes? J Urol. 2019 Dec;202(6):1150-1158. doi: 10.1097/JU.0000000000000392. E PMID 31216252
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PMID 18929686
  • Alayed Y, Davidson M, Quon H, Cheung P, Chu W, Chung HT, Vesprini D, Ong A, Chowdhury A, Liu SK, Panjwani D, Helou J, Musunuru HB, Pang G, Korol R, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Commisso A, Commisso K, D'Alimonte L, Ho L, Bhounr Z, Loblaw A. Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. Radiother Oncol. 2020 Mar;144 PMID 31809979
  • Matsushima M, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Ohashi T, Mikami S, Miyajima A, Shigematsu N, Oya M. Erectile function status is highly associated with prostate-specific antigen bounce in localized prostate cancer patients treated with permanent prostate brachytherapy. Int J Urol. 2016 Mar;23(3):247-52. doi: 10.1111/iju.13029. Epub 2015 Dec 12. PMID 26663514

Идентификаторы

NCT: NCT07460726 · 1219

Первоисточники (государственные реестры)

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